Duns Number:388240673
Device Description: Quantitative determination of retinol-binding protein in human serum and plasma on BN Syst Quantitative determination of retinol-binding protein in human serum and plasma on BN Systems
Catalog Number
OUVO09
Brand Name
N Antiserum to Human RBP
Version/Model Number
10446494
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CZS
Product Code Name
RETINOL-BINDING PROTEIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
c183bbed-41c1-4407-8e81-002e0f942943
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |